Clinical Systems IT Manager

Clinilabs; Eatontown, Northern (NJ, KY); Hybrid; USD 120,000 - 130,000; Full time

Job summary

Clinilabs seeks a Clinical Systems Information Technology Manager to own Corelab IT systems and lead technology strategies for clinical applications.

You will manage SDLC and release processes across AWS and GCP regulated systems, oversee vendors, drive validation, and coordinate with leaders, developers and QA to ensure compliant, reliable operations.

Qualifications

• Bachelor’s degree in computer science, information systems or related field; extensive experience may substitute.
• Seven years in IT engineering and data management in life sciences or CRO.
• Three years of IT management leading internal resources and vendors.
• Leadership in software design, implementation and operations.
• Experience with SDLC and regulated GxP environments is preferred.

Responsibilities

• System owner and technology lead for Corelab business unit systems and applications.
• Work with AWS provider and internal teams to maintain architecture and design docs.
• Maintain SDLC and release management for GCP regulated systems.
• Project management for application development and system design.
• Oversee AWS services to ensure recoverability and backups per DR policy.
• Follow change management and create change controls for updates.
• Prepare vendor qualification audit materials for regulators and sponsors.
• Participate in validation activities including requirements gathering and UAT.
• Provide input on development projects and new technology for Corelab functions.
• Serve as technical resource for support requests and ensure timely resolution.
• Ensure compliance with CFR 21 Part 11, GCP, HIPAA, GDPR, ICH and regional guidance.
• Perform other duties to support IT operations, security, and compliance.

Skills

System owner

Tech leadership

Project management

Regulatory compliance

Communication

SDLC knowledge

Agile & Waterfall

Vendor management

Education

Bachelor's degree in Computer Science

Tools

SQL

M365

AWS

Linux

DNS

CDN

Job description

The Clinical Systems Information Technology Manager serves as systems owner and technology leader for Corelab information technology clinical systems and applications.

RESPONSIBILITIES

• System owner and technology lead for Corelab business unit systems and applications
• Work with Clinilabs AWS provider and internal resources to build and maintain architecture and design documents of Clinilabs clinical systems
• Maintain and execute Clinilabs SDLC and release management for GCP regulated clinical systems
• Project management, both agile and waterfall, for application development and system design, build implementation, providing direction to Clinilabs software development vendor partner
• Operationally oversee Clinilabs AWS service provider to ensure Corelab clinical systems do not run into capacity issues, backups are run, patches are applied and systems always remain recoverable in alignment with Clinilabs DR policy
• Adhere to change management procedures, creating change controls for updates to Corelab systems
• Prepare and present vendor qualification audit materials to regulatory authorities, sponsors and other customers
• Participate in validation activities including requirements gathering, SOP authoring and user acceptance testing
• Provide input on development projects and implementing new technology related to Corelab functions or other Clinilabs’ clinical systems in support of clinical studies
• Serve as technical resource for internal and external support requests related to Corelab computer and other clinical application systems ensuring timely resolution
• Follow and ensure compliance with current regulatory requirements Title CFR 21 Part 11, GCP, HIPAA, GDPR, ICH and other regional regulatory guidance
• Perform other related duties as assigned to support IT operations, security, compliance, and business objectives

Salary range between $120,000 - $130,000. Final compensation is based on skills, experience, location, and overall expertise.

TRAVEL

This is a remote position with occasional travel to the Eatontown, NJ office.

Requirements

REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES

• This position requires a bachelor’s degree in computer science, information systems or a related field. Extensive relevant experience may be considered in lieu of a degree
• Seven years of experience in information technology engineering and data management within a life sciences or contract research organization
• Three years’ IT management experience leading internal resources and vendors
• Leadership experience in software application design, implementation and operations is required
• Must demonstrate competence in both waterfall and agile project management methodologies, including planning, execution, stakeholder communication, and delivery oversight
• Experience managing data acquisition systems, transfer protocols and data lifecycle management
• Demonstrated experience working with web hosted applications, SQL, M365, AWS, Linux, DNS, CDN technologies with data management systems
• Comprehensive knowledge of software development life cycle (SDLC) processes
• Strong understanding of software application architecture, including component design, application interactions, backend server configuration, and ongoing system management
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with business leaders, application developers, DBAs and vendors to gather and translate business requirements
• Requirements gathering and execution of validation deliverables in a GCP environment
• History of work in a regulated GxP, life sciences, pharmaceutical, or related environment is highly preferred and will be considered a strong differentiator for qualified candidates